BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 22240977 · Received June 17, 2025

    Report

    Report Number
    2024800-2025-00034
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 17, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045505711
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. SUSPECTED POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLES. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 915709 ON THE PANTHER PLUS INSTRUMENT (SERIAL NUMBER (B)(6). SAMPLE ID (B)(6) INITIALLY RESULTED CT POSITIVE AND GC EQUIVOCAL UNDER (B)(6). THE SAME SAMPLE WAS RETESTED AND RESULTED CT NEGATIVE AND GC NEGATIVE ON (B)(6). CUSTOMER CONFIRMED THAT THE DUAL NEGATIVE RESULT (CT NEGATIVE / GC NEGATIVE) WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450072 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 915709 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other